Here you can edit and choose your personal newsletter preferences and skip topics you’re not interested in.
(you can choose as many as you want!)
The legal action of the FDA against Bar Pharmaceuticals resulted in a ruling which established formally the need to carry out an investigation if something went wrong. This was followed by the publication of the Out of Specification [OOS] guidance in 1998. Al though these rules were primarily directed at the investigation of analytical results the door was opened...Continue reading
Day 1-morning
Section 1 Introduction
Section 2 Root Cause Analysis–General Concepts & Processes
Day 1-afternoon
Section 3 Data Collection
Section 4 Causal Analysis
Day 2 morning
Section 5 Change Analysis And Barrier Analysis
Section 6 RCA High Level Techniques
Day 2-afternoon
Section 7 Establishing RCA in a Company
Section 8 RCA as a Technique in Trouble Shooting & Technology Transfer
A consideration of how some RCA techniques can be applied to trouble shooting and technology transfer issues
Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems.
They will be shown how Root Cause Analysis is an investigative technique that can provide the answers to many of the problems that occur in a company, ranging from administration to purchasing, to production, to R&D and QC through all aspects of quality assurance.
Systems for causal analysis and techniques of data collection will be considered together with change analysis, barrier analysis and event and causal factor charts.
In particular they will consider the work environment needed for RCA to be effective how to set up and maintain an RCA group in a company.
Attendees will see some specific industrial examples as to how RCA can be applied in a variety of situations ranging from technology transfer to troubleshooting.
Here you can edit and choose your personal newsletter preferences and skip topics you’re not interested in.
(you can choose as many as you want!)